BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
- Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight
- Accomplishes tasks through direct and effective coordination
- Provides direction and hands-on training for staff
- Management of staff
- Lives department values and sets the standards for others to operate
- Fosters an environment of compliance, strong work ethic and ongoing learning
- Ability to take responsibility for complex projects
- Effective interaction with peers across manufacturing to create alignment and improvement
- Partners with support groups (Facilities, Validation, MSAT, Quality) to complete scheduled activities
- Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance
- Ability to troubleshoot, identify issues and support resolutions with technical groups
- Required to perform ongoing operational tasks in respective work area
- Uses scientific thinking and decision making in daily work
- Proven experience with relevant process, theory and equipment
- Experience with process automation and functionality
- Assist with review and approval of documentation including Batch Records and logbooks
- Technical Documentation:
- Provide feedback and/or suggested changes to operational procedures
- Assist in the incorporation of new technologies, practices and standards into procedures
- Capable of writing and reviewing process documents
Quality and Compliance
- Complete understanding and adherence to cGMP’s as related to commercial operations
- Initiate and own required Corrective and Preventative actions and lead change control actions
- Support the closure of manufacturing discrepancies and change requests
- Current understanding of FDA and EMEA guidelines, cGMP's for Manufactured Drug Products
- Experience with business systems (Process historian, LIMS, Trackwise, ERP, MES, )
- Support trending and communication of defined department metrics
- Identify and drive opportunities for process & business optimization
- Translates company and department goals into actionable objectives for self and staff
- Other duties as assigned.
B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.
4+ years of directly related industry experience, including at least 2+ years with proven leadership role
Ability to independently manage work, actions and expectations is essential
NIGHT SHIFT DETAILS:
- Thurs-Sat, alt Wed, 1800-0700
- MFG area is specific to Drug Substance Purification - however either upstream or downstream experience will be considered.
- 100% time on-site
**We do provide Shift Differential pay for any off-hour shifts including Swing and Grave**
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.